Our client a global medical device company currently seeks a Clinical Project Manager to join their team. The Clinical Project Manager is responsible for overall project management of clinical evaluation activities to facilitate full compliance with the new European Union Medical Device Regulation (EU MDR). The Project Manager will define and drive strategic objectives to actions and deliverables through methodical planning, resourcing, executing and controlling projects from start to finish. The PM will take program and project ownership while guiding teams through execution. The Project Manager ensures consistent and compliant practices throughout all phases of the project life cycle and across functional teams.
• Facilitates communication between the Medical Writer (internal or external vendor), Business Unit teams and Medical Director to ensure on-time delivery of high-quality regulatory documents for medical devices.
• These regulatory documents include: Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports Summary of Safety & Clinical Performance (SSCPs) and may include Post Market Clinical Follow Up (PMCF) plans and reports.
• Manages the successful completion of deliverables for regularly scheduled updates of CER, and SSCP documentation as well as ad-hoc updates.
• Develops deliverable project plans/schedules; working closely with the Global Scientific Affairs management, medical writers and BU teams to ensure timelines are met.
• Schedules deliverable kick-off meetings to confirm deliverable scope, project schedule, assigned SMEs, and availability of source documentation.
• Responsible to drive the effort in successfully delivering the required documents by the required timelines. If anything places that delivery at risk, collaborates with cross functional business partners to mitigate that risk.
• Proactively partners with cross functional business partners for example: broader Post Market Surveillance (PMS) team, risk management teams, QA/RA.
• Implements an effective communication model and tools with cross functional team members that provides deliverable status updates and supports timely completion of deliverables.
• Anticipates potential deliverable schedule conflicts and challenges for proactive solutions.
• Ensures escalation of risk management response strategies to Global Scientific Affairs Management
• Through the implementation of project management and productivity tool, maintain and track progress and produce applicable reports
• Partner with other project leaders to ensure coordination of activities and timelines, facilitating efficient use of resources to ensure compliant deliverables
• Partner with Regulatory and Quality Operations as well as IT project management to develop systems and IT tools requirements to support effective standard processes
Skills / Experience:
• Bachelor of Science/Arts degree in business or a technical, engineering, or science discipline and at least 3 years’ experience in medical device related field. During or additional to those years of experience, direct project management experience is required.
• PMP certification preferred.
• MS project experience desirable • Knowledge of Design Controls and experience with FDA and ISO regulations.
• Requires track record of detailed program management exhibiting comprehensive planning and thorough communication. Experience using MS Project or equivalent tools to schedule and manage development projects.
• Must be proficient participating in cross-functional teams, as well as coordinating and communicating to multiple stakeholders. Able to manage project prioritization, scheduling, resource utilization, budgeting, and performance validations.
• Excellent written and oral communication skills.
• Have a flexible mindset, able to work in a fast-changing environment with competing priorities
For further information please contact James Cassidy firstname.lastname@example.org or call in confidence 0860204322